Demonstration Studies

PCORI-funded PCORnet Demonstration Studies aim to prove PCORnet capacity, while answering critical research questions. They fall into one of four initiatives: Interventional Studies, Obesity Observational Studies, Patient-Powered Research Network (PPRN) Studies, and Health Systems Studies. While they are all designed to answer important patient-centered, comparative effectiveness research questions and demonstrate PCORnet capabilities, each initiative is also uniquely designed to test key aspects of PCORnet functionality.

Demonstration Study Initiatives

Interventional Studies

This initiative is comprised of the ADAPTABLE aspirin study, PCORnet’s first pragmatic, randomized, controlled clinical trial. ADAPTABLE is integrated with routine clinical care and health care delivery. It is designed to test the ability to ascertain patients aided by electronic health records (EHRs); work with centralized IRBs and electronic informed consent; and patient recruitment.

Associated Studies

Obesity Observational Studies

These studies employ an observational design and test the technical and operational aspects of PCORnet’s Distributed Research Network (DRN) in addition to standardized capture of a wide range of claims, EHR, and prescription data in the Common Data Model (CDM).

Associated Studies

Patient-Powered Research Network (PPRN) Studies

The PPRN Studies are designed to test the ability to conduct research that addresses the concerns of patient network members via patient-identified research questions that have been prioritized by PPRN community stakeholders and participants. PPRN studies include both observational and randomized controlled trials.

Health Systems Studies

These studies test PCORnet’s ability to engage health systems leaders and clinicians across Clinical Data Research Networks (CDRNs); to do focused and agile research that leverages the Common Data Model (CDM) and new health system data; and to do analyses rapidly and iteratively with systems leaders to facilitate their development of Learning Health Care Systems. Learning Healthcare Systems, as defined by the Institute of Medicine (IOM), are designed to emphasize a collaborative approach that shares data and insights across boundaries to drive better, more efficient medical practice and patient care.

Compares the effectiveness of two daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. What we learn from the ADAPTABLE study will improve care and outcomes for patients with heart disease and could prevent as many as 88,800 deaths per year around the world. ADAPTABLE is considered a pragmatic trial and is therefore designed to reflect “real-world” medical practice, with the actual work of the study taking place in a variety of clinical settings and amongst a broad patient population. Learn more on the ADAPTABLE Website and follow ADAPTABLE on Facebook and Twitter.

PCORnet Bariatric Study

Compares the one, three, and five-year health benefits of three common bariatric procedures; analyzing changes in weight, rate of remission, rate of diabetes relapse or improvements, and risk of major adverse health events. The study will also explore patient perspectives on their key choices regarding bariatric surgery, such as whether to have surgery, which procedure is right for them, and receipt of follow-up care. Learn more on the Obesity Studies Webpage.

Assesses the relationship between antibiotic use in the first two years of life and weight gain in later childhood, by examining different types of antibiotics, different amounts of antibiotics, and timing in the first two years of life. It measures body mass index (BMI) at ages 5 and 10, and growth trajectories out to 5 years of age. Previous research has shown a link between the use of antibiotics, particularly wide-spectrum antibiotics, and an increased risk for obesity. Learn more on the Obesity Studies Webpage.

Comparative Effectiveness of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn's Disease

Looks at the relationship between dietary patterns and treatment of Crohn's Disease (CD) by comparing two different diets, specific carbohydrate diet (SCD) and Mediterranean-Style Diet (MSD). SCD restricts all but simple carbohydrates, while MSD emphasizes consumption of fresh fruits and vegetables, lean meats, and olive oil.

Focuses on improving decision making when choosing treatments for autoimmune and inflammatory diseases, including rheumatoid arthritis, inflammatory bowel disease, juvenile arthritis, psoriasis, and vasculitis . The study looks at the relationship between newer biologic agents being used to treat these diseases and important safety events of hospitalized infection, heart attack, stroke, and cancer.Project and Award Summary

Healthy Hearts Healthy Minds

Compares two treatments designed to help individuals who have mood disorders and who are also at risk for, or have heart disease, to increase their physical activity. Individuals are randomized into two groups, web-based cognitive behavioral therapy or web-based mindfulness-based cognitive therapy, to determine which intervention works best to enhance exercise and create easy access to interventions after the study is completed.

Healthy Mind Healthy You: A Study of Mindfulness

Healthy Mind Healthy You is unique in that it is a large cross-PPRN study, meaning it demonstrates scientific, administrative, and operational capacity to collaborate across multiple PPRNs. The study aims to determine the minimally effective "dose" of mindfulness for helping with stress and improving overall well-being. It randomizes participants into two groups, one receiving eight online mindfulness-based treatment sessions and the other receiving only three sessions.

Monitoring and Peer Support to Improve Treatment Adherence and Outcomes in Patients with Overlap Chronic Obstructive Pulmonary Disease and Sleep Apnea via a Large PCORnet Collaboration (O2VERLAP)

Tests the effectiveness of two strategies designed to improve adherence and patient outcomes among patients using oxygen and positive airway pressure therapy (PAP). These results will provide answers for providing efficient education coaching platforms as well as remove barriers to treatment adherence.

Resiliency Education to Reduce Depression Disparities

Focuses on depression among Lesbian, Gay, and Bisexual (LGB) adults by comparing two different methods to improve depression outcomes. Patients are randomized into two groups, with one group participating in a depression Quality Improvement (QI) program, while the second group participates in the same QI program that is also supplemented with B-RICH+ (Building Resiliency and Increasing Community Hope + a mobile/interactive voice response case management tool to reinforce class content and depression care reminders).

Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions

This study will support patients and clinicians in working together using mHealth enabled N-of-1 trials to answer patient generated research questions from two PPRN’s—the ImproveCareNow (ICN) network and the Health eHeart (HeH) network. The first aim is to use a series of N-of-1 trials to determine the effectiveness of specific carbohydrate diet (SCD) versus a more liberal version of the diet in improving clinical symptoms and reducing inflammation among individuals suffering from inflammatory bowel disease (IBD). The second aim is to test the effectiveness of N-of-1 trials versus data tracking alone in helping patients identify and eliminate personal triggers to reduce the frequency and severity of their atrial fibrillation (AF).Project and Award Summary

INITIATIVE: HEALTH SYSTEMS STUDIES

Automating Quality and Safety Benchmarking for Children: Meeting the Needs of Health Systems and Patients

Aims to test the use of data drawn directly from electronic health records to compare performance of health systems in healthcare safety and quality. The study focuses on the quality and safety of outpatient pediatric healthcare and will measure three different topics. First, Transcranial Doppler (TCD) screen for children with sickle cell disease; second, appropriate antibiotics for ear infections; and third, cholesterol and glucose testing for children on antipsychotic medications.Project and Award Summary

Identifying and Predicting Patients with Preventable High Utilization

Focuses on patients with high healthcare use. This study creates data sets and tools to identify and characterize patient groups with preventable high use. It then compares the effectiveness of different methodological approaches and data sources to predict a patients’ annual risk profile of potentially falling into one of the identified preventable high-use groups.

The Impact of Patient Complexity on Healthcare Utilization

Examines whether or not factors such as where a patient lives, how much money they have, or if they graduated high school have an effect on how patients use healthcare services and how healthy they are. It also looks at whether being diagnosed with multiple conditions means that the patients and health systems have poorer outcomes.

Analyzes case management programs to help health systems understand how to design case management programs that can better support older patients. The goal for these new case management programs is to assist older patients who are seeing multiple physicians and frequently receiving health care from the emergency department or hospital.Project and Award Summary

*All Demonstration Studies were either solely or partially supported through Patient-Centered Outcomes Research Institute (PCORI) Program Awards.

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